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Androgen Suppression With Abiraterone, Leuprolide, PARP Inhibitor and Stereotactic Radiotherapy in Prostate Cancer (ASCLEPIuS)

Clinicaltrials.gov identifier:
NCT04194554

Treatment
Newly diagnosed prostate cancer grade group 3-5

Study Contact Information:

For additional information, contact:
Cancer AnswerLine: 800-865-1125
or by email at:  [email protected]  

Androgen Suppression With Abiraterone, Leuprolide, PARP Inhibitor and Stereotactic Radiotherapy in Prostate Cancer (ASCLEPIuS)

About the Study

This study will look at treating men with high risk cancer using the ,  combined with stereotactic body radiotherapy (SBRT), , leuprolide, and prednisone. Phase 1 of this study will look at the best dose of  for this treatment combination. The phase 2 portion of this study will look at the 3-year recurrence free-survival rate of the patients who received this combined therapy.

What the Study Entails

This is an open label, single-group study.

  • All participants will receive the same study combination and will know which treatments they are receiving. 

All study participants will receive the following:

  • will be administered orally once per day on a dose escalation schedule to determine the most tolerable and effective dosage (although will be withheld for several days before, during, and after SBRT when administered in the lower doses).
  • acetate will be administered orally every day.
  • Leuprolide will be administered once every three months via an intramuscular injection.
  • Prednisone will be given orally twice per day, or at the clinic’s discretion.
  • Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable .
  • Study participants will be followed up to 5 years after their first dose of .


Study Locations

Michigan
Ann Arbor, MI
University of Michigan Rogel Cancer Center    
Contact: Cancer AnswerLine: 800-865-1125
or by email at:  [email protected]  
Principal Investigator: William Jackson, MD       

New York
New York, NY
Weill Cornell Medicine
Contact: Sharanya Chandrasekhar, MS: 646-962-2196
or by email at:  [email protected]     
Contact: Pragya Yadav, PhD: 646-962-2199
or by email at: [email protected]        
Principal Investigator: Himanshu Nagar, MD      

Ohio
Cleveland, OH
University Hospitals Seidman Cancer Center 
Contact: Daniel Spratt, MD:  216-293-6191      
or by email at: [email protected]
Principal Investigator: Daniel Spratt, MD        

Texas
Dallas, TX
University of Texas Southwestern   
Contact: Cancer AnswerLine at UTSW: 833-722-6237 
or by email at: [email protected]     
Principal Investigator: Neil Desai, MD, MHS           

This Study is Open To:

Men age 18 years or older who meet the following criteria:

  • Has cancer (already confirmed with a biopsy) and meets Gleason score grade group and test criteria as defined by the study team, with at least one of the following criteria:
    • cN1 on conventional or PET imaging
    • Grade group 5
    • Grade group 4 and ≥10 ng/mL
    • Grade group 3 and ≥20 ng/mL
    • High probability of Radiographic T3 on AND Grade group ≥2
    • Grade Group 3 AND ≥10 ng/mL AND ≥50% positive biopsy cores
  • Tissue available for testing
This Study is Not Open To:

People with the following are not eligible:

  • Evidence of disease by CT/bone scan
  • Had prior pelvic radiation therapy
  • Significant heart disease
  • Lack of available tissue from biopsy
  • Had prior treatment for cancer (including TURP, chemotherapy, radiation therapy, or anti-androgen therapy)